Behavioral Science Aspects of Rapid Test Acceptance (BSARTA)

California State University, Long Beach

Status: Completed

Conditions: Syphilis; Hepatitis C; HIV; Hepatitis B

Treatments: Device: HIV/HCV; Device: HIV/syphilis; Device: HIV only; Device: Rapid tests for HIV, HCV, HBV, and syphilis

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01317784

07373710

R01DA030234 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The relevance of this research to public health is to make it possible to test for hepatitis C and syphilis at point of care so that people will receive their results immediately instead of requiring people to wait for at least a week to get their test results. This research will make rapid tests for HIV available that can detect HIV infection earlier and are more accurate than current tests available in the United States.

Full description

This application addresses "Studies to improve access and utilization of HIV counseling and testing" for "HIV/AIDS and AIDS-related co-infections" such as "hepatitis C virus (HCV), other sexually transmitted infections (STIs)" that are part of PA-07-307 Drug Abuse Aspects of HIV/AIDS. The only rapid tests that are approved for use in the US currently are for HIV infection. Tests for other conditions such as hepatitis C (HCV) and syphilis are in use in other countries. In response to an Opportunity that the CDC published in the Federal Register, there are now candidate rapid test kits for HCV and syphilis available for experimental use in the US. Different combinations of rapid and standard tests will be offered to participants in a four-arm trial to assess which tests are accepted by the participants. Only a minority of clients at CBRS who have been offered the rapid test for HIV have accepted it. Those who chose rapid HIV tests were more likely to be male, educated, gay, young and White. They were less likely to be Black, or injection drug users. The proposed study has the potential to have a significant impact upon screening for HIV, syphilis, and HCV. Rapid tests have the potential to increase the receipt of test results, particularly among groups that are less likely to return for their results using traditional testing. The candidate tests are designed for Point of Care (either oral fluid and/or whole blood), and thus will require real-time testing, so the trial will be able to evaluate both the accuracy of the tests in settings of intended use and their acceptability to potential clients in real-world situations.

Enrollment: 1,200 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Over 17 years old
• Mentally stable
• Sober
• Able to understand English or Spanish
• At least one good vein for phlebotomy
• Member of Behavioral Risk Group

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,200 participants in 4 patient groups

All tests.

Experimental group

Description:

Choose from all 16 possible tests.

Treatment:

Device: Rapid tests for HIV, HCV, HBV, and syphilis

HIV/HCV

Active Comparator group

Description:

Choice of 10 different HIV and hepatitis C tests in the bundle.

Treatment:

Device: HIV/HCV

HIV/Syphilis

Active Comparator group

Description:

Choice of 7 different tests for HIV and syphilis.

Treatment:

Device: HIV/syphilis

HIV only

Active Comparator group

Description:

Choice of 4 rapid tests for HIV only.

Treatment:

Device: HIV only